Boston Scientific · 3 hours ago
Principal Design Quality Engineer - WATCHMAN
Maple Grove, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$102K/yr - $194K/yr
8+ years expBoston Scientific is a leader in medical science, committed to solving important health industry challenges. The Principal Design Quality Engineer will support WATCHMAN new product development projects within the Cardiology division, leading a team to ensure compliance with design controls and quality standards during product development.
Health CareMedicalMedical Device
No H1B
Responsibilities
In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams
Support the execution and documentation of Design Validation & Verification and Usability activities
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications)
Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
Lead and support cross-functional root-cause analysis investigation and resolution activities
Support regulatory submissions to notified bodies
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related Engineering field of study
Minimum of 8 years of experience in design assurance, quality, or related medical device or regulated industry experience
Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation
ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
Excellent organizational and planning skills; drives for results
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to travel up to 10%
Preferred
Experience in developing test methods
Experience supporting clinical trials
Problem solver, capable of facilitating the problem-solving process
Adaptable and effective collaborator in a team environment and in self-directed work
Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups
Experience with Class III Medical Devices
Benefits
Relocation assistance is available for this position at this time.
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
Company data provided by crunchbase